Summary of Requirements for New Drug Submission - Trinidad ...
Summary of Requirements for New Drug Submission - Trinidad ...
Summary of Requirements for New Drug Submission - Trinidad ...
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
TRINIDAD AND TOBAGO<br />
MINISTRY OF HEALTH<br />
CHEMlSTRYlFOOD AND DRUGS DIVISION<br />
SUMMARY OF REQUIREMENTS FOR NEW DRUG SUBMISSION<br />
(I) Certificate in respect <strong>of</strong> Imported <strong>Drug</strong>s<br />
Free Sale Certificate - Original<br />
or<br />
Certificate <strong>of</strong> Pharmacelitical Product - Original<br />
(2) Chemical Documentation<br />
(A)<br />
Finished Product<br />
Specifications<br />
Method <strong>of</strong> Analysis<br />
Certificate <strong>of</strong> Analysis - Original<br />
Stability Data<br />
Disintegration<br />
Dissolution Pr<strong>of</strong>ile<br />
Three (3) Samples<br />
(ElJ<br />
Active Ingredientb)<br />
(3) Pharmaceutical Documentation<br />
Specifications<br />
Method <strong>of</strong> Analysis<br />
Certificate <strong>of</strong> Analysis (each ingredient) - Original<br />
One (1) gram <strong>of</strong> each<br />
(A)<br />
Pharmacodynamic data<br />
General Pharmacology<br />
Tests supporting efficacy<br />
(B)<br />
Pharmacokinetic data<br />
Distribution<br />
Biotrans<strong>for</strong>mationlMetabolism<br />
Excretion<br />
Biological equivalence
(C)<br />
Pharmacotherapeutic data<br />
Therapeutic uses<br />
Clinical trials<br />
Therapeutic equivalence<br />
(D)<br />
Toxicity data<br />
All types<br />
N.B. Data: - Published and In-house.<br />
(4) Manufacturing Details<br />
Manufacturinglunit Composition Formula<br />
Brief Manufacturing DirectionlProcedure<br />
Brief Manufacturing Controls<br />
Sampling and Testing Procedures<br />
GMP Certificate<br />
(5) Packaqing Materials (Containers and Closures)<br />
(6) Ink and Printing<br />
(7) Package Insert<br />
Description<br />
Composition<br />
Size and dimension requirements (guage, thickness, etc.)<br />
with target value and acceptable tolerances<br />
Colour<br />
Processes necessary to make the article acceptable<br />
to pharmaceutical production (e.g, coating, washing,<br />
sterility <strong>of</strong> surfaces, etc.)<br />
Samples<br />
Colour<strong>of</strong>lnk<br />
Chemical Composition <strong>of</strong> Ink<br />
Description <strong>of</strong> Ink (colourfast, light resistant, rub<br />
resistant, reflectance, etc.)<br />
Other characteristics <strong>of</strong> Ink (odour, distribution, etc.)<br />
Printing - capacity to smear, smudge, sc<strong>of</strong>f or be<br />
removed during normal handling <strong>of</strong> the package<br />
Where applicable (Prescription <strong>Drug</strong>s)<br />
Standard <strong>Requirements</strong>
SUBJECT :<br />
NEW DRUG SUBMISSIONS - GUIDELINES<br />
In order to expedite the processing <strong>of</strong> your <strong>New</strong> <strong>Drug</strong> <strong>Submission</strong>s, please ensurelprovide: -<br />
A. (1) The <strong>New</strong> <strong>Drug</strong> <strong>Submission</strong> Forms are filled out properly.<br />
As much in<strong>for</strong>mation as possible must be filled out on<br />
the <strong>for</strong>ms ~rovided.<br />
You may use a blank sheet <strong>of</strong> paper if more space<br />
is necessary and attach to the <strong>for</strong>m.<br />
DO NOT PUT - "SEE DOSSIER"<br />
(Photocopy <strong>of</strong> the <strong>for</strong>m is acceptable)<br />
(2) All relevant technical data such as -clinical studies,<br />
product description, product <strong>for</strong>mulationlspecification,<br />
methods <strong>of</strong> analysis, certificate <strong>of</strong> analysis to support<br />
each new <strong>Drug</strong> <strong>Submission</strong>.<br />
B. Each drug is properly certified -original "Free Sale Certificate"/"Certificate<br />
<strong>of</strong> Pharmaceutical Product" (CPP) required from the Health Authorities.<br />
C. Two (2) samples <strong>of</strong> each drug in its finished pharmaceutical<br />
<strong>for</strong>m in which it is to be sold.<br />
D. Samples <strong>of</strong> the active ingredient(s).<br />
E. REGISTRATION FEE: $750.00 (T.T.) payable in advance.<br />
(Items A. (1) & (2) must be in duplicate).
m<br />
For Official Use<br />
Receiving No:<br />
Control No:<br />
DAN No:<br />
To be filled out by Applicant upon presentation <strong>of</strong><br />
<strong>New</strong> <strong>Drug</strong> <strong>Submission</strong>/Supplemental <strong>Submission</strong><br />
(1) Name <strong>of</strong> Dru.dForm/Strenfzth :........................................................................<br />
(2) Name and Address <strong>of</strong> Manufacturer or :......................<br />
......................................<br />
Distributor:. ................................................................................................<br />
(3) Phone Number (if local manufacturer):. ...............................................................<br />
(4) Countrv <strong>of</strong> Origin: ........................................................................................<br />
(5) Name & Address <strong>of</strong> Importer:. ..........................................................................<br />
(6) Phone Number: .............................................................................................<br />
(7) List <strong>of</strong> ingredients (Active Only]<br />
NAME QUANTITY NAME QUANTITY
Change language